Metabolic Effects of Accurate Blood Sugar Results and Education in Type 1 Diabetes

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 1

• Registration Number: NCT00284232
• Lead Sponsor: Helse Stavanger HF

Brief Summary

A randomized controlled trial in patients with type 1 diabetes, assessing the metabolic effects of accurate blood sugar results and education. A systematic approach in self-monitoring blood glucose will improve metabolic control in type 1 diabetes patients. Education in SMBG combined with a high analytical quality instrument for SMBG, introduced in a systematic and thorough way will improve HbA1c by 0,5% and keep it over a period of 9 months.

Detailed Description

* Written informed consent 130 patients with type 1 diabetes to be included

* age 18-70

* HbA1c of 8% or higher, variation in HbA1c over the last 18 months sholuld be \<1,5%

* Treated with multiple insulin injections or insulin pumps

* Variation in weight less than 5kg within last year

* Using SMBG on a daily basis

* Mental capacity and stability to participate

* No hypoglycemia unawareness

* No likelihood that patient will drop out or not perform according to protocol

* Continious recruitment from the outpatient clinic at Stavanger University Hospital from October 2004-October 2005

* 9 months follow-up

* Possible 12 month extension after initial

* Intervention group receives new SMBG instrument, education and advice on treatment changes at baseline, 1,2,3,6 and 9 months. Control group continues regular care following national guidelines of Norway. This includes visits usually every 3-6 months at the outpatient clinic and possibly with their GP in addition.

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2006-01-27
• Study First Submitted QC: 2006-01-27
• Study First Posted: 2006-01-31
• Primary Completion: 2006-08
• Study Completion: 2006-12
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-27
• Last Update Posted: 2015-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Hba1c 8% or higher, less than 1,5% variation within last year
• Age 18-70
• Multiinjections or insulin pumps
• Stable weight (<5kg variation last year)
• Mentally stable

Exclusion Criteria

• Hypoglycemia unawareness
• Mental incapacity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HbA1c %	9 months

Secondary Outcome Measures

Name	Time	Method
Hypoclycemic events	9 months
New learning points for patients	9 months
Confidence in new instrument quality	9 months
Measurement quality of blood glucose instrument	9 months
Frequency of SMBG	9 months
Satisfaction	9 months

Trial Locations

Locations (1)

Stavanger University Hospital; 🇳🇴 Stavanger, Norway